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This device is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract. It is also indicated in adults for endoscopic dilatation of Sphincter of Oddi with or without prior sphincterotomy.

According to the structure of the device, it can be divided into three types, RX type, OTW type and OTW with Stainless Wire-guided type. The Rx proposed device mainly consists of tip, balloon, marker band, shaft, sleeve, stress diffusion tube and hub. The OTW proposed device mainly consists of tip, balloon, marker band, shaft, stress diffusion tube and hub. The structure of the OTW with Stainless Wire-guided model same with the structure of OTW model. The difference between OTW with Stainless Wire-guided type catheter and OTW type catheter is that OTW with Stainless Wire-guided type catheter is preloaded with a guide wire and a guide wire locking component. The difference between the RX type catheter and the OTW series catheter is that the guidewire exit position is different. The guide wire of OTW series catheter passed through the guide wire lumen of the catheter. The guidewire of the Rx type catheter will pass through the guidewire exchange port on the shaft.

Single-use Balloon Dilatation Catheter is divided into different specifications. Shafts are available in two different diameters. The effective length of the catheter is 180cm and 240cm. Balloon diameters are available in six different diameters 6-7-8mm, 8-9-10 mm, 12-13.5-15 mm, 15-16.5-18 mm, 18-19-20 mm, and the balloon lengths are available in 30 mm,55 mm and 80 mm three different length.

The provided FDA 510(k) summary for the "Single-use Balloon Dilatation Catheter" (K241888) details a non-clinical study to demonstrate substantial equivalence to predicate devices, rather than an AI/ML software performance study. Therefore, most of the requested information regarding AI/ML device acceptance criteria, human reader studies, and ground truth establishment for AI/ML models is not applicable to this document.

The document describes performance testing for a physical medical device. Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "All the test results demonstrate proposed device meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide a specific table detailing the exact quantitative acceptance criteria for each test and the corresponding measured performance values. It lists the types of tests performed.

2. Sample sizes used for the test set and data provenance:
The document states "The performance testing conducted on subject device and predicate device are listed below." and mentions "ASTM F3172 Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices". This suggests that standard device testing sample sizes were used in accordance with this guideline, but the specific sample sizes for each test are not explicitly stated in this summary.
Data provenance: This is a physical device, so "data provenance" would refer to the testing conditions and results. The tests were performed in a lab setting to verify design specifications and compliance with international standards (e.g., ISO, ASTM, USP). The country of origin for the testing is not specified, but the applicant company is Leo Medical Co., Ltd. in China. The data is prospective as it's generated through device testing.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This question is not applicable as this is a physical device performance study, not a study involving human reader interpretation of images or AI/ML model output requiring "ground truth" established by experts in a clinical context. The "ground truth" for these tests are the physical measurements and compliance with engineering and material standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as it's a physical device performance study. Adjudication methods are typically for clinical consensus on ground truth in image interpretation or diagnosis, not for engineering performance tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. No MRMC study was performed as this is not an AI/ML-assisted diagnostic device. The document explicitly states: "No clinical study is included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This is not an algorithm, but a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this physical device, the "ground truth" for the non-clinical tests is based on established engineering and material science standards, measurements, and pre-defined acceptance criteria. For example, burst pressure is measured against a standard, biocompatibility is assessed against ISO 10993, and sterility against ISO 11135.

8. The sample size for the training set:
This is not applicable. No training set was used as this is a physical device, not an AI/ML model being "trained."

9. How the ground truth for the training set was established:
This is not applicable. No training set was used.

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The device is designed to be used with an Endoscope to deliver a Ligation Loop designed to control bleeding following polypectomy of pedunculated polyps.

The Ligation Device is sterile and single-use, which consists of two main components, ligation loop and delivery system. And these two components provided in different sizes to consist different specifications of ligation device.

The document provided is a 510(k) premarket notification for a medical device called "Ligation Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or diagnostic accuracy through extensive clinical trials. Therefore, much of the requested information regarding clinical study setup, acceptance criteria, multi-reader multi-case studies, and ground truth establishment, which are typical for AI/ML-driven diagnostic devices, is not applicable or not present in this regulatory submission.

However, I can extract information related to non-clinical testing and performance comparisons.

1. A table of acceptance criteria and the reported device performance

The submission does not specify numerical "acceptance criteria" for the non-clinical tests in the usual sense (e.g., a specific threshold for release force). Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The "reported device performance" is implicitly that it passed these tests and was comparable to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical study is included in this submission." Therefore, there is no clinical test set, sample size, or data provenance information provided in this regulatory document. The evaluations were non-clinical (benchtop and biocompatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set or ground truth established by experts is mentioned in this non-clinical submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication process is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical ligation device, not an AI-assisted diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical ligation device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For the non-clinical tests, "ground truth" would be the direct measurement results (e.g., force values, cytotoxicity assays) compared against predefined specifications or predicate device performance.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a mechanical device, not an AI/ML model requiring a training set and associated ground truth.

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